Syntel Thrombectomy Catheter
9 catalogue numbers from A4534, listed by Applied Medical Resources Corp., United States, under Catheter, Embolectomy. 1 manufacturer in China is registered for this product code.
1manufacturer
9catalogue numbers in this listing
4510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
Record
| Listed by | Applied Medical Resources Corp., United States |
|---|---|
| FDA product code | DXE |
| Device type | Catheter, Embolectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5150 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2016-08-18 |
| Record revised | 2022-10-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
| Sizes | Length 40 to 80 cm; catheter gauge 3 to 6 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A4534 | Catheter Gauge 3 Fr | In distribution |
| A4518 | 8/10 French | In distribution |
| A4538 | Length 80 cm | In distribution |
| A4545 | Length 50 cm | In distribution |
| A4554 | Catheter Gauge 5 Fr | In distribution |
| A4544 | Length 40 cm | In distribution |
| A4568 | Catheter Gauge 6 Fr | In distribution |
| A4558 | Catheter Gauge 5 Fr | In distribution |
| A4548 | Length 80 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LeMaitre Embolectomy Catheter | Lemaitre Vascular, Inc. | 68 |
| LMI Arterial Embolectomy Catheter | Lucas Medical, Inc. | 63 |
| Indigo System | Penumbra Inc. | 60 |
| Fogarty | Edwards Lifesciences Technology Sarl | 44 |
| Arrow | Teleflex Medical LLC | 28 |
| Bard Latex-free Arterial Embolectomy Catheters | Applied Medical Resources Corp. | 22 |
| Biosensors Embolectomy Catheter | Bioptimal International Pte. Ltd. | 16 |
| Amplatz Goose Neck | Covidien LP | 15 |
| Amplatz Goose Neck™ | ev3, Inc. | 13 |
| LMI Thrombectomy Catheter | Lucas Medical, Inc. | 12 |
| LMI Occlusion Catheter | Lucas Medical, Inc. | 12 |
| Syntel Silicone OTW Embolectomy Catheter | Lemaitre Vascular, Inc. | 9 |
Showing 12 of 88. All products under Catheter, Embolectomy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202049 | 2021-09-07 |
| K973465 | 1998-02-19 |
| K970762 | 1997-03-28 |
| K950586 | 1995-05-15 |
Recalls
3 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-10-24 | Class I | Component change control | The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter. | 28,799 catheters in total | 2023-06-01 |
| 2019-10-24 | Class I | Component change control | The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter. | 28,799 catheters in total | 2023-06-01 |
| 2019-10-24 | Class I | Component change control | The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter. | 28,799 catheters in total | 2023-06-01 |
| 2012-08-09 | Class II | Material/Component Contamination | Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product. | 40,238 units for all products in Recall Event | 2013-03-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.